Trial Information

The study is an open label, multicenter phase IIa clinical trial which is designed as a
pilot project in order to establish the efficacy and tolerability of Multiferon as a
neoadjuvant treatment of locoregional metastases. Patients will be treated subsequently in
cohorts characterized by different doses (3 - 9 - 18 MIU) to analyze dosage dependent
effects.

Inclusion Criteria:

1. Histologically proven cutaneous melanoma

2. Clinical stage IIIB or IIIC (AJCC 2010)

3. ≥ 18 years of age

4. Presence of at least two metastases, not more than 10 metastases, and completely
resectable

5. Measurable disease (at least one lesion that can be accurately measured in two
perpendicular diameters, with both dimensions at least 10 mm x 10 mm for spiral CT
and 5 mm x 5 mm for locoregional metastases assessed by ultrasound or digital
photography)

6. ECOG performance status of 0/1

7. Patients with previous adjuvant recombinant interferon-α treatment of any dose are
eligible if (i) treatment was stopped at least 1 month before start of treatment and
(ii) no progression occurred during interferon-α treatment.

8. No childbearing potential or negative pregnancy test within 14 days before inclusion
in women with child bearing potential Women with childbearing potential must be using
an effective method of contraception (Pearl-Index < 1, e.g. oral contraceptives,
other hormonal contraceptives [vaginal products, skin patches, or implanted or
injectable products], or mechanical products such as an intrauterine device or
barrier methods [diaphragm, spermicides]) throughout the study and for up to 3 months
after the last dose of investigational product, in such a manner that the risk of
pregnancy is minimized.

No men of fathering potential or men of fathering potential must be using an
effective method of contraception to avoid conception throughout the study and for up
to 3 months after the last dose of investigational product, in such a manner that the
risk of pregnancy is minimized.

9. Signed and dated informed consent informed consent before the start of specific
protocol procedures

Start Date:

Completion Date:

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